Senior Specialist, GMP Operational Quality

Job Title: Senior Specialist, GMP Operational Quality
Company: Intellectt Inc
Location: Boston, MA
Pay: $50/hr on W2
Work Environment: Onsite

Job Summary:
Seeking a Senior Quality Specialist to provide Quality Assurance oversight for clinical and commercial drug product manufacturing. This role supports GMP compliance, manufacturing floor operations, batch record review, product disposition, investigations, and inspection readiness.

Key Responsibilities

• Review batch documentation, including manufacturing records, deviations, in-process results, environmental monitoring data, and QC release testing.
• Support product disposition and release decisions, including resolution of quality issues affecting shipment.
• Approve Certificates of Analysis (CoAs), generate BSE/TSE statements, and support product labeling activities.
• Archive batch records and supporting documentation in the electronic Document Management System (eDMS).
• Provide manufacturing floor QA support and guidance on GMP compliance.
• Review and approve manufacturing documents.
• Perform raw material release, area and line clearance, and equipment release activities.
• Provide QA oversight for change controls, GMP investigations, root cause analysis, and corrective and preventive actions (CAPAs).
• Support equipment, utility, and facility qualification activities and associated site programs.
• Participate in QA walkthroughs, inspection readiness, and closure of audit observations.
• Identify quality risks and process gaps, communicate concerns, and drive timely resolution.
• Collaborate with cross-functional teams to improve quality processes and support site projects.

Required Qualifications

• Master's degree in a relevant field with 2 3 years of relevant experience, or a bachelor's degree in a scientific or allied health field with at least 5 years of relevant experience, or a comparable background.
• Experience providing QA oversight of GMP manufacturing operations, including batch release and equipment, facility, and utility qualification.
• Experience leading quality investigations, root cause analysis, and CAPA activities.
• Demonstrated ability to independently lead cross-functional teams and resolve quality issues.
• Experience with systems such as Oracle and Veeva.
• Strong knowledge of GMP requirements, quality systems, and documentation practices.
• Strong communication, organizational, and problem-solving skills.
• Ability to work second shift onsite in Boston, five days per week.

Name: Soundarya Kondra
Email:

soundarya.kondra@intellectt.com

Benefits:
Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements
Equal Employment Opportunity:
Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k)-retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO other than that required by applicable state and local laws